The New Cyber Rulebook Every EU MedTech Start-up Should Know
Connected medical devices are brilliant—but they’re magnets for hackers. That’s why the EU has rolled out two big pieces of legislation that tighten the screws on cybersecurity:
Cyber Resilience Act (CRA) – product-level rules
NIS2 Directive – organisation-wide rules
Below is a fast, founder-friendly guide—easy to read, under 1,000 words, and packed with the keywords and trust cues Google loves.
1. CRA in a Nutshell
What Why it matters to MedTech Timeline Became EU law 10 Dec 2024; fully applies 11 Dec 2027. Scope “Products with digital elements.” Medical devices already covered by MDR/IVDR are formally exempt from separate CRA CE-marking, but the same cyber bar still applies. Core duties • Secure-by-design/default firmware & software
• Lifecycle vulnerability management
• 24-hour early-warning to ENISA/CSIRT if a flaw is actively exploited.Penalties Up to €15 m or 2.5 % of global turnover for missing essential cyber requirements. Translation for start-ups: You must build and ship patchable devices, keep a Software Bill of Materials (SBOM), and have a playbook for racing out fixes when something breaks.
2. NIS2 at a Glance
| What | Why it matters to MedTech |
|---|---|
| Who’s covered? | Hospitals = “essential entities.” Medium-to-large device makers = “important entities.” Yes, manufacturers are in scope. |
| Key obligations | • Enterprise-level cyber risk management (think ISO 27001) • Supply-chain security controls • Named exec liability for repeat non-compliance |
| Incident drill | 24 h early warning → 72 h detailed notice → 1 month final report. |
| Sanctions | Up to €10 m or 2 % of turnover plus possible management bans |
Bottom line: Even if your gadget is small, once you scale, sell widely or host cloud services, you’ll need a company-wide security program, not just secure code.
3. Why Founders Feel the “Cybersecurity Squeeze”
Double paperwork. MDR/IVDR already expects cyber risk files (see Annex I + MDCG 2019-16 guidance). CRA adds more detail; NIS2 adds organisational controls.
Clashing clocks. Same breach could trigger MDR (safety, 15 days), CRA (cyber, 24 h) and NIS2 (business impact, 24 h) reports, three authorities, three tickers.
Certification anxiety. Industry body MedTech Europe warns against duplicating CE routes and audit fees under CRA.
Resource strain. Third-party security assessments, 24/7 monitoring, and ISO-style policies are tough on lean teams.
4. Five-Step Survival Plan for Start-ups
Bake cyber into your QMS. Fold threat modelling, SBOMs, pen-test results, and patch policy into your ISO 13485 design controls. One set of documents can satisfy MDR, CRA, and many NIS2 items.
Map your reporting matrix. Draft a single incident-response SOP that lists who you notify and when (ENISA, national CSIRT, competent authority, data-protection office). Run tabletop drills so your team can hit those 24-hour clocks.
Use harmonised standards. IEC 81001-5-1 (health-software security), IEC 62304 (software lifecycle) and ISO 27001 cover 90 % of CRA/NIS2 technical asks. Build to them now; auditors will thank you later.
Design for painless patching. Auto-update mechanisms, segmented architectures, and remote kill-switches reduce scramble time when CVEs drop. Remember: CRA says fixes must roll out “without undue delay.”
Show your work. Publish a “security” page, vulnerability-disclosure mailbox, and short white paper on how you meet CRA/NIS2/MDR. Buyers and investors treat open security posture as a trust badge—great for SEO and sales.
5. Key Take-Aways
Same direction, different angles. CRA secures devices, NIS2 secures organisations—and MDR/IVDR already secures patients.
Early action beats late panic. Build secure-by-design now; retrofitting in 2027 will be brutal.
Compliance = competitive edge. Hospitals pick vendors who won’t land them multimillion-euro fines or front-page breaches.
About the Author
Highstage helps MedTech innovators turn regulatory hurdles into launchpads. Our team blends ISO 13485 expertise, real-world pen-testing, and process automation to keep your QMS—and your Google rankings—in top shape.
Last updated: 5 June 2025. All legislative timelines verified against EU Commission and official directive texts.
Sources referenced for the article
“Cyber Resilience Act | Shaping Europe’s digital future” – European Commission Digital-Strategy portal. digital-strategy.ec.europa.eu
“EU’s Cyber Resilience Act (CRA) is officially published” – BSI Group blog. bsigroup.com
“Cyber Resilience Act” – Overview page, German Federal Office for Information Security (BSI). bsi.bund.de
“EU Cyber Resilience Act (CRA)” – Open Source Security Foundation policy resource. openssf.org
“NIS2 Directive: new rules on cybersecurity of network and information systems” – European Commission Digital-Strategy portal. digital-strategy.ec.europa.eu
“The NIS 2 Directive – implications for the healthcare sector and manufacturers of medical devices” – Fieldfisher insight article. fieldfisher.com
“NIS2 is here – What life-sciences and healthcare providers need to know about Europe’s new cybersecurity regime” – Shoosmiths LLP. shoosmiths.com
“It’s the Final Countdown: NIS 2 – implications for the health sector” – Shoosmiths LLP. shoosmiths.com
MDCG 2019-16 Rev.1 – Guidance on Cybersecurity for Medical Devices – European Commission / Public Health PDF. health.ec.europa.eu
“MDCG endorsed documents and other guidance” – European Commission medical-devices guidance portal. health.ec.europa.eu
“MedTech Europe provides feedback on the Cyber Resilience Act” – MedTech Europe news release. medtecheurope.org
“Proposal for a Regulation on horizontal cybersecurity requirements… (Cyber Resilience Act)” – MedTech Europe position paper. medtecheurope.org
“The NIS2 Directive involves medical-device manufacturers” – Sistemir blog. sistemir.com
“Commission implementing regulation on critical entities and networks – NIS2” – European Commission. digital-strategy.ec.europa.eu
